EUCTR2014-005011-17-NL
Active, not recruiting
Not Applicable
ano MRI on 7 Tesla: A technical validation study in rectal and breast cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ymph node metastases in rectal cancer, breast cancer and cancer in general
- Sponsor
- Radboudumc
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •General criteria:
- •\-Age \> 18 years
- •Inclusion criteria rectal cancer patients:
- •\-Patients with recently histologically proven rectal cancer, who are planned to undergo a total mesorectal excision without neo\-adjuvant radiotherapy.
- •Inclusion criteria breast cancer patients:
- •\-Patients with recently histologically proven breast cancer (Stage II), who are planned for surgery with sentinel node procedure, but will receive no neo\-adjuvant therapy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 30
Exclusion Criteria
- •General exclusion criteria:
- •\-BMI \> 30 kg/m2
- •\-Pregnancy
- •\-Karnofsky score \<\= 70
- •\-Contraindications for 7T MRI:
- •oInability to provide informed consent
- •oMetal implants that are not compatible with 7 Tesla MRI
- •\-Contraindications to USPIO based contrast agents:
- •oprior allergic reaction to ferumoxtran\-10 or any other iron preparation
- •oprior allergic reaction contributed to dextran or other polysaccharide, in any preparation
Outcomes
Primary Outcomes
Not specified
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